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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
491

Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it matter if a dose card was not included? To summarize, does a demo kit fit Code Section 6.6 (iv) .....use of a drug name only in a context not linked to therapeutic or promotional messages. Or is it considered a Service-Oriented Vehicle under Code section 6.4, even if it's a demo kit?

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490

Good afternoon! I am with the Canadian Medical Association and we have recently attended the Association Quebecoise des Chirurgiens AGM event. We asked for the list of attendees so we can gauge how many of them are members, and the event organiser informed us that under "new code of ethics guidelines", she is not permitted to share the list with us. Is this accurate information? Would she be referring to your guidelines, or others? Thank you!

489

Where can I get the detail guidance around layouts (ie, font size, specific/mandatory placement of info etc)? Thanks.

488

What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)

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487

Hi PAAB, would product related messages posted on the intranet of a company for employees' information be considered direct to consumer advertisement, given that the intranet is accessible to any employee of the company but not to people from the outside? Thank you!

486

Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!

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485

If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?

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484

What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?

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483

In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?

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482

Is it acceptable to use Data on File such as a PSUR to support non-clinical statements such as patient exposure? If so, what format should the Data on File take as it is not possible/desirable to provide the whole document as data on file. Thank you.

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Deputy Commissioner  

Patrick Massad
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